Overweight and ObesityNCT01476436
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
A study testing Low carbohydrate dietary advice and Continue usual diet in people with Overweight and Obesity and Type IIb Hyperlipidaemia, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Low carbohydrate diet may influence the plasma lipid levels. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type IIb Hyperlipidaemia, Hypercholesterolemia Aggravated
- What is being tested?
- Low carbohydrate dietary advice and Continue usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNorway
- Study dates
- Nov 2011to 22 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Any disease or use of prescriptional medication
Trial locations and contacts
2 sites in 1 country.
About this study
Low carbohydrate diet may influence the plasma lipid levels.
Read the detailed description
Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period
- Being tested
- Low carbohydrate dietary advice, Continue usual diet
- Keywords
- Cardio vascular risk factors
- Medical subject headings
- Overweight, Obesity, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietary adviceOther
Also called Dietary advice
Dietary advice
Continue usual dietOther
Also called Lifestyle counseling to continue usual diet
Dietary advice
| Study group | Role | What they receive |
|---|---|---|
| LCHF diet | Experimental | Advice of a diet low in carbohydrate Receives: Other: Low carbohydrate dietary advice; Other: Continue usual diet |
| Usual diet | Active comparator | Subjects shall continue to eat their usual daily diet with no low carbohydrate intervention Receives: Other: Continue usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet
Measured: From baseline to study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completion22 Sep 2017
- Study completion22 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Kjetil Retterstøl, Oslo University Hospital
- Investigators
- Kjetil Retterstøl, MD PhD, Principal investigator, University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476436
- Sponsor's protocol ID
- REK195276
- Status last verified
- Oct 2018
- First submitted
- 11 Aug 2011
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
- ClinicalTrials.gov ID
- NCT01476436
- Acronym / sponsor ID
- REK195276
- Keywords
- Cardio vascular risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Nov 2011
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low carbohydrate diet may influence the plasma lipid levels.
Detailed description
Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate diet or usual diet for a period
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCHF diet | Experimental | Other: Low carbohydrate dietary advice, Other: Continue usual dietAdvice of a diet low in carbohydrate |
| Usual diet | Active comparator | Other: Continue usual dietSubjects shall continue to eat their usual daily diet with no low carbohydrate intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (1 listed)
- Any disease or use of prescriptional medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietary adviceAlso: Dietary adviceDietary advice | Other | LCHF diet |
| Continue usual dietAlso: Lifestyle counseling to continue usual dietDietary advice | Other | LCHF diet, Usual diet |
Primary outcome
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet
Time frame: From baseline to study end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjetil Retterstøl, MD PhD principal investigator
University of Oslo, Faculty of Medicine, Institute of Basic Medical Sciences, Department of Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate dietary advice and Continue usual diet in people with Overweight and Obesity and Type IIb Hyperlipidaemia, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in mean LDL-cholesterol after intervention with low carbohydrate diet (time frame: From baseline to study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.